Cosmetics: How FDA Evaluates the Regulatory Status of Products

Event Information
Product Format
Prerecorded Event
60 minutes
Product Description

Drug vs. Cosmetics – Learn How FDA Determines Regulatory Status


The webinar by our expert speaker Will Woodlee will focus on the U.S. Food and Drug Administration’s (FDA’s) rules for marketing beauty and personal care products as cosmetics and avoiding charges of unapproved drug promotion. Woodlee will explain the differences in the cosmetic and drug categories, including the regulatory requirements that make marketing drugs much more burdensome and costly.

You will learn about how FDA determines the regulatory status—drug versus cosmetic—of beauty and personal care products under the “intended use” doctrine.  After reviewing key FDA positions as well as enforcement precedents and trends, you will be provided with practical tips for marketing these products as cosmetics consistent with current FDA policies.

Session Highlights:

  • Just what qualifies a beauty or personal care product as a “drug” versus a “cosmetic,” and why does it matter?
  • How does FDA determine a beauty or personal care product’s “intended use” for evaluating its regulatory status?  Will putting “cosmetic” on the label do the trick?
  • What kinds of claims could make my beauty or personal care product a drug?
  • Has FDA really taken enforcement action in this area?  What are the trends?
  • How might I revise my marketing materials to lower the risk of FDA objection?
  • Can a product qualify as both a drug and a cosmetic?  How would that work?

Session Benefits:

You will gain a detailed understanding of:

  • The differences in the “drug” and “cosmetic” regulatory categories;
  • How the differences in regulatory requirements for drugs and cosmetics make the regulatory status question so important;
  • How FDA evaluates the intended use of a beauty or personal care product to determine its regulatory status;
  • Key FDA positions on drug versus cosmetic claims;
  • Trends in FDA assertion of drug status against beauty and personal care products; and
  • Tips for promoting beauty and personal care products as cosmetics and to avoid drug charges

Who Should Attend

  • Employees of manufacturers
  • Distributors, and retailers of cosmetics
  • Attorneys
  • Regulatory affairs specialists and marketing professionals serving the industry
  • Investors
  • Entrepreneurs
  • Scientists and government employees interested in learning more about regulation of the category and advertising issues

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About Our Speaker

Will Woodlee

Will Woodlee is a partner in the law firm of Kleinfeld, Kaplan, and Becker, LLP, in Washington, DC. His practice focuses primarily on counseling and advocating on behalf of food, dietary supplement, cosmetic, pharmaceutical, medical device, tobacco product, and consumer product companies on regulatory and advertising law matters. In 2015, Super Lawyers named Mr. Woodlee a "Rising Star" of the Washington, DC, metro area's “Food & Drugs” bar....   More Info
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We regret to announce that ProEdTech LLC and all its affiliate brands will cease operations on April 1, 2019.


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